Drugs
A 1/5-2/9 FDA inspection at the Denison Pharmaceuticals drug manufacturing facility in Lincoln, RI, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs, and other violations. A 7/26 Warning Letter says specific CGMP violations were: * failing to thoroughly investigate any unexplained discrepancy
Drugs
FDA has accepted a Servier sNDA and will give priority review for Tibsovo (ivosidenib) to treat IDH1-mutated relapsed or refractory myelodysplastic syndromes (MDS). A company statement says that if the indication is approved, Tibsovo would be a first-in-class targeted therapy option for MDS patients within the molecularly
Drugs
The Fifth Circuit Court of Appeals has ruled that the abortion drug mifepristone can remain on the market while litigation continues, but it should be available under the conditions for use that existed in 2016 until final judgment. In 2016, FDA approved a supplemental NDA that removed several restrictions on
Drugs
Federal Register notice: FDA is issuing an order debarring Ildiko M. Knoll for five years from importing or offering for import any drug into the U.S. The order is based on an FDA investigation that showed Knoll imported 100 parcels (18,435 pieces; 9,495 tablets) containing erectile dysfunction
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) issued an 8/4 Warning Letter to AstraZeneca about a professional sales aid for its Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol for oral inhalation use. The letter is the first Warning Letter issued by OPDP this year. “The sales
Drugs
FDA has published a guidance, Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors, to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with the agency’s informed consent regulations for clinical investigations. The document supersedes a 9/1998 guidance and finalizes a 7/2014 draft guidance.
Drugs
FDA has lifted a partial clinical hold against an Arcellx IND for CART-ddBCMA, an investigational drug for treating patients with relapsed or refractory multiple myeloma. The hold was ordered in June following a recent patient death. At the time, the company said it believed “limitations on bridging therapy are
Drugs
FDA has approved Delcath Systems’ Hepzato Kit (melphalan for injection/hepatic delivery system) for liver-directed treatment in adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or
Drugs
FDA has denied a St. Jude Children’s Research Hospital petition asking the agency to ease the current contradiction in codeine-containing analgesics to read that codeine should not be used to treat pain or cough in children under age 12 except for specified exceptions. The proposed language would say
Drugs
FDA commissioner Robert Califf says the Office of Dietary Supplement Programs (OSDP) will be reporting to the Office of Food Chemical Safety, Dietary Supplements, and Innovation in the agency’s new Human Foods Program that is being developed. In an online blog post, Califf says the new structure “is designed
Drugs
Oncopeptides says it is going to file a formal appeal of FDA’s recent request for the company to voluntarily withdraw its accelerated-approved multiple myeloma drug Pepaxto (melphalan flufenamide). This looks to be the first test of the modified authority FDA was granted late last year under the Food
Drugs
FDA has accepted and will give priority review to a Venatorx Pharmaceuticals NDA for cefepime-taniborbactam to treat complicated urinary tract infections (cUTI), including pyelonephritis, in adults. The company says the agency set 2/22/2024 as the PDUFA action date for the NDA. It says the NDA is supported
Drugs
FDA has granted Pfizer accelerated approval for Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager for treating adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an
Drugs
FDA has issued Biocon an eight-item Form FDA-483 after a 7/12-20 inspection of the firm’s Johor, Malaysia manufacturing facility cited significant GMP deficiencies. For example, the inspection observations said the firm’s procedures designed to prevent microbiological contamination are not established, written, or followed. The
Drugs
Florida has amended a lawsuit against FDA charging the agency with violating the Freedom of Information Act (FOIA) by withholding records requested by the state relative to its application to permit the importation of Canadian drugs. The 8/14 amended suit seeks FDA records, requested in a May FOIA filing,
Drugs
FDA has placed a clinical hold on a 2seventy bio Phase 1 study (PLAT-08) of SC-DARIC33 in acute myeloid leukemia after a patient death was reported. The company says it and partner Seattle Children’s have been conducting an internal investigation and root cause analysis of the serious
Drugs
FDA has accepted for review an Astellas Pharma supplemental NDA for Cresemba (isavuconazonium sulfate), a prodrug of isavuconazole, an azole antifungal for treating invasive aspergillosis (IA) or invasive mucormycosis (IM) in pediatric patients aged one to 17 years old. The submission is based on data from a Phase 2 open-
Drugs
FDA has updated its Web page on “Questions and Answers on Current Good Manufacturing Practice Regulations — Production and Process Controls” to address whether parametric release is an appropriate control strategy for sterile drug products that are not terminally sterilized. According to the new post, parametric release is only appropriate for
Drugs
FDA has granted Genprex an orphan drug designation for Reqorsa immunogene therapy (quratusugene ozeplasmid) and its use for treating small cell lung cancer. Genprex says its method is to re-express tumor suppressor genes in cancers, and Reqorsa contains a plasmid that expresses a tumor suppressor gene protein called TUSC2.
Drugs
FDA has published a draft guidance, Classification Categories for Certain Supplements Under BsUFA 3, with recommendations on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved section 351(k) applications. The document says the BsUFA 3 agreement sets forth the
Drugs
FDA has granted accelerated approval to Janssen’s Talvey (talquetamab-tgvs), described as a first-in-class bispecific therapy to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38
Drugs
FDA has published a draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products, describing FDA’s requirements on and providing recommendations for obtaining safety and effectiveness information on drugs, when appropriate, in the postmarketing setting in historically underrepresented patient populations in